Low profile intraluminal suturing device and method

ABSTRACT

An improved suturing device and method is provided. The suturing device is of the type including a guide body and means on the guide body for translating at least one needle relative to the guide body. The suturing device is improved by providing a rotatable sleeve disposed over at least a distal portion of the guide body to facilitate introduction of the device to a puncture site.

This is a Continuation of application No. 08/491,496 filed Jun. 15, 1995still pending, the disclosure of which is incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to apparatus and methods for thepercutaneous closure of body lumens. More particularly, the presentinvention relates to apparatus and methods for the percutaneous closureof arterial and venous puncture sites, which are usually accessible onlythrough a tissue tract.

A number of diagnostic and interventional vascular procedures are nowperformed transluminally, where a catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access which is usually established usingthe well known Seldinger technique, as described, for example, inWilliam Grossman's "Cardiac Catheterization and Angiography," 3rd Ed.,Lea and Febiger, Philadelphia, 1986, incorporated herein by reference.

When vascular access is no longer required, the introducer sheath mustbe removed and bleeding at the puncture site stopped. One commonapproach for providing hemostasis (the cessation of bleeding) is toapply external force near and upstream from the puncture site, typicallyby manual or "digital" compression. This approach suffers from a numberof disadvantages. It is time-consuming, frequently requiring one-halfhour or more of compression before hemostasis is assured. Additionally,such compression techniques require clot formulation and thereforecannot begin until anticoagulants used in vascular therapy procedures(such as for heart attacks, stent deployment, non-optimal PTCA results,and the like) are allowed to wear off. This can take up to two to fourhours, thereby increasing the time required under the compressiontechnique. The compression procedure is further uncomfortable for thepatient and frequently requires administering analgesics to betolerable. Moreover, the application of excessive pressure can at timestotally occlude the underlying blood vessel, resulting in ischemiaand/or thrombosis. Following manual compression the patient is requiredto remain recumbent for at least four and at times longer than 12 hoursunder close observation to assure continued hemostasis. During this timerenewed bleeding may occur resulting in bleeding through the tract,hematoma and/or pseudo aneurysm formation as well as arteriovenousfistula formation. These complications may require blood transfusionand/or surgical intervention. The incidence of these complicationsincreases when the sheath size is increased and when the patient isanticoagulated. It is clear that the standard technique for arterialclosure can be risky, and is expensive and onerous to the patient. Whilethe risk of such conditions can be reduced by using highly trainedindividuals, such use is both expensive and inefficient.

To overcome the problems associated with manual compression, the use ofbioabsorbable fasteners to stop bleeding has been proposed by severalgroups. Generally, these approaches rely on the placement of athrombogenic and bioabsorbable material, such as collagen, at thesuperficial arterial wall over the puncture site. While potentiallyeffective, this approach suffers from a number of problems. It can bedifficult to properly locate the interface of the overlying tissue andthe adventitial surface of the blood vessel, and locating the fastenertoo far from that surface can result in failure to provide hemostasisand subsequent hematoma and/or pseudo aneurysm formation. Conversely, ifthe fastener intrudes into the arterial lumen, intravascular clotsand/or collagen pieces with thrombus attached can form and emboliesdownstream causing vascular occlusion. Also, thrombus formation on thesurface of a fastener protruding into the lumen can cause a stenosiswhich can obstruct normal blood flow. Other possible complicationsinclude infection as well as adverse reactions to the collagen implant.

A more effective approach for vascular closure has been proposed in U.S.Pat. No. 5,417,699 and in co-pending application Ser. Nos. 08/148,809and PCT/US93/11864. A suture applying device is introduced through thetissue tract with a distal end of the device located at the vascularpunctures. One or more needles in the device are then used to drawsuture through the blood vessel wall on opposite sides of the punctures,and the suture is secured directly over the adventitial surface of theblood vessel wall to provide highly reliable closure.

While a significant improvement over the use of manual pressure, clamps,and collagen plugs, certain design criteria have been found to beimportant to successful suturing to achieve vascular closure. Forexample, it is important that the needles be properly directed throughthe blood vessel wall so that the suture is well anchored in tissue toprovide for tight closure. It is also important that needle deploymentwithin the suturing device be controlled to prevent accidentaldeployment before the device has been properly introduced to thepuncture site in a blood vessel. It is of further importance that thevascular suturing device be able to be introduced to blood vesselswithout imposing significant or undue trauma to the patient. Inparticular, it is particularly desirable to close the vessel in arelatively short amount of time and without imposing excessive injury tothe tissue tract leading to the vessel.

For these reasons, it would be desirable to provide apparatus, systems,and methods for suturing vascular punctures which meet all or some ofthe criteria discussed above.

2. Description of the Background Art

Devices capable of delivering pairs of needles to various tissuelocations are described in the following patents and patentapplications: U.S. Pat. Nos. 4,493,323 and 659,422; European patentapplication 140 557; and U.S.S.R. patent applications 1174-036-A and1093-329-A. A suturing device that carries a pair of needles havingsuture therebetween is described in a brochure entitled "Innovationthrough Progress," REMA-MEDIZINTECHNIK, Gmbh, January, 1992. A suturingdevice having a partially flared cylindrical core for delivering needlesto suture anastomoses is described in U.S. Pat. No. 4,553,543. Othersuturing and ligating devices are described in U.S. Pat. Nos. 5,171,251;5,160,339; 4,317,445; 4,161,951; 3,665,926; 2,959,172; 2,646,045; and312,408. Devices for sealing percutaneous vascular punctures usingvarious plugs and fastener structures are described in U.S. Pat. Nos.5,222,974; 5,192,302; 5,061,274; 5,021,059; 4,929,246; 4,890,612;4,852,568; 4,744,364; 4,587,969; and 3,939,820. Collagen fastenersealing devices are under commercial development by Datascope Corp.,Montvale, N.J., and Kensey Nash Corporation, Exton, Pa. Copendingapplication Ser. No. 08/148,809, describes a vascular suturing devicehaving a needle guide with a constant peripheral dimension.

SUMMARY OF THE INVENTION

The present invention provides improved apparatus, systems, and methodsfor suturing percutaneous luminal puncture sites, particularly vascularpuncture sites located at the distal end of a percutaneous tissue tract.The improvements are most applicable to paired-needle suturing systems,such as those described in U.S. Pat. No. 5,417,699 and in co-pendingapplication Ser. No. PCT/US93/11864, and particularly for the suturingsystem described in co-pending application Ser. No. 08/252,124, filedJun. 1, 1994. The disclosures of all these references are hereinincorporated by reference. At least some of the improvements, however,will be equally applicable to single-needle suturing systems, such asthose described in co-pending application Ser. No. 08/148,809, thedisclosure of which is herein incorporated by reference, as well asother types of suturing devices known and described in the medical andpatent literature.

In one particular aspect, the present invention provides an improvedsuturing device of the type including a guide body and means on theguide body for translating at least one needle relative to the guidebody. Such a suturing device is improved by providing a rotatable sleevedisposed over at least a distal portion of the guide body. The rotatablesleeve will usually comprise a rigid cylinder having a length in therange from 30 mm to 200 mm and a diameter in the range from 3 mm to 15mm. Such a sleeve is particularly advantageous in facilitatingintroduction of the suturing device to the puncture site and eliminatesthe need for a predilator.

In another aspect, the suturing device is further provided with aflexible tube extending distally from the guide body. The flexible tubeincludes a proximal end, a distal end, and a guide wire lumen extendingproximally from the distal end and terminating in an exit port betweenthe proximal and distal ends. Such a guide wire exit port isparticularly useful in allowing the suturing device to be introducedinto the blood vessel over a guide wire in a "monorail" fashion (i.e.with the guide wire exiting somewhere along the length of the suturingdevice and then running along the outside of the remainder of thedevice). In this way, the profile of the guide body may be kept minimalto reduce the overall size of the device. Further, such a configurationallows the guide wire to be removed from the vessel prior introductionof the guide body into the tissue tract. Preferably, the flexible tubehas a length in the range from about 20 cm to 40 cm, and the exit portis located at about 5 cm to 20 cm from the proximal end. In a furtheraspect, the flexible tube has an outside diameter in the range fromabout 2 mm to 10 mm. In yet another aspect, the flexible tube includes acentral lumen extending distally from the proximal end for housing theneedle during insertion of the suturing device.

In a further aspect, the suturing device will preferably include a meansfor selectively preventing rotation of the sleeve relative to the guidebody. In an exemplary embodiment, the preventing means will comprise ahandle attached to the guide body, with the handle having at least onedetent for engaging a groove in the sleeve. In still another aspect, atleast one blood detection lumen that passes through the guide body isprovided and is used in positioning the suturing device within the bloodvessel. In a particularly preferable aspect, a suture lumen is furtherprovided in addition to the blood detection lumen. The suture lumenpasses through the guide body and stores at least part of a length ofsuture during insertion of the suturing device. Optionally, the suturelumen may also function as a blood detection lumen so that the device isprovided with a second or "back-up" blood detection lumen.

The invention further provides an improved suturing device of the typeincluding a guide body and means on the guide body for translating atleast one needle relative to the guide body. The improvement comprises aflexible tube having a proximal end connected to the guide body, adistal end, and a guide wire exit port between the proximal end and thedistal end. The flexible tube preferably has a length in the range fromabout 20 cm to 40 cm, with the exit port being located at about 5 cm to20 cm from the proximal end. In another aspect, the flexible tube has anoutside diameter in the range from about 2 mm to 10 mm. In a furtheraspect, the flexible tube includes means for directing a proximallyadvanced guide wire through the exit port.

In a particularly preferable aspect, the suturing device furtherincludes a sleeve rotatably disposed about the guide body. The rotatablesleeve is preferably a rigid cylinder having a length in the range from30 mm to 200 mm and a diameter in the range from 3 mm to 15 mm. Inanother aspect, a means is provided for selectively preventing rotationof the sleeve. An exemplary preventing means comprises a handle attachedto the guide body, with the handle having at least one detent forengaging a groove in the sleeve. In still a further aspect, at least oneblood detection lumen passing through the guide body is provided. Aseparate suture lumen may also be provided to house a length of suture.In this manner, improved suture management is provided to facilitateeasier reciprocation of the needles through the suturing device whenclosing the vessel.

The invention provides an exemplary suturing device comprising a guidebody having a proximal end, a distal end, and an internal lumen. Aneedle guide is provided having a proximal end attached to the distalend of the guide body and a distal end having at least two needle guidechannels. A pair of needles are provided along with a length of suturehaving two ends, with each end attached to one of the needles and withat least a portion of the remaining length of suture passing through theinternal lumen of the guide body. A shaft is provided and isreciprocatably mounted within the guide body. The shaft carries theneedles and allows the needles to be reciprocated within the needleguide channels.

In one particular aspect, the suturing device further includes a pair ofreceiving channels in the guide body which are arranged so thatreciprocation of the shaft draws the needles into the receiving channelsand draws the length of suture from the internal lumen. In this way, thelength of suture may be stored both within the guide body and outsidethe patient until the needles are reciprocated to close the vessel. In apreferable aspect, the suturing device will further include a blooddetection lumen passing through the guide body. The blood detectionlumen will preferably be employed in positioning the suturing devicewithin the vessel. Optionally, the internal lumen having the length ofsuture may also function as a blood detection lumen so that the suturingdevice will be provided with a "back-up" detection lumen in the eventthat the blood detection lumen (without the length of suture) becomesclogged or otherwise non-operational.

In another aspect, the suturing device includes a sleeve that isrotatably disposed about the guide body. The sleeve is preferably arigid cylinder having a length in the range from 30 mm to 200 mm and adiameter in the range from 3 mm to 15 mm. In a further aspect, a meansis provided for selectively preventing rotation of the sleeve. In stilla further aspect, the preventing means comprises a handle attached tothe guide body, with the handle having at least one detent for engaginga groove in the sleeve. In one particularly preferable aspect, a meansis provided for releasably securing the shaft to the guide body toprevent relative axial movement. In this way, needle deployment may beprevented during introduction of the suturing device to the puncturesite.

In yet another aspect, the suturing device includes a flexible tubehaving a proximal end connected to the needle guide, a distal end, and aguide wire exit port between the proximal end and the distal end. Theflexible tube preferably has a length in the range from about 20 cm to40 cm, and the exit port is located at about 5 cm to 20 cm from theproximal end. In still a further aspect, the flexible tube has anoutside diameter in the range from about 2 mm to 10 mm. In yet anotheraspect, the flexible tube includes means for directing a proximallyadvanced guide wire through the exit port.

The invention provides an exemplary method for suturing a puncture sitein a blood vessel wall disposed at the distal end of a percutaneoustissue tract. According to the method, a suturing device is providedhaving a guide body, a sleeve rotatably disposed about the guide body,and a distally extending flexible tube. The suturing device isintroduced to the puncture site so that the guide body lies within thetissue tract and the flexible tube lies within the blood vessel lumen.During insertion of the guide body into the tissue tract, the sleeve isrotated to facilitate introduction. Once positioned at the puncturesite, a needle carrying a length of suture is drawn from the tubethrough the blood vessel wall adjacent the punctures and outward throughthe tissue tract. A loop in the suture is then secured to close thepunctures.

In one particular aspect, a pair of needles having the length of suturetherebetween are simultaneously drawn through the blood vessel wall toform the loop. Preferably, at least a portion of the length of sutureextending between the pair of needles passes through the guide body andis disposed outside the patient during introduction of the device. Thelength of suture is then pulled back through guide body during thedrawing step. In one aspect, the needle is prevented from being deployedduring the introducing step. In a further aspect, the sleeve is securedrelative to the guide body after the rotating step.

In yet another aspect, the introducing step further comprises insertingthe flexible tube over a guide wire and advancing the tube over theguide wire until the guide wire exits an exit port in the flexible tube.The tube is then further advanced until the tube is within the bloodvessel. The guide wire is then withdrawn from the puncture site so thatthe guide body may be introduced into the tissue tract. In still anotheraspect, the suturing device is positioned by observing blood flow from amarker lumen in the guide body having a side or marker port between theflexible tube and the distal end of the guide body. In another aspect,the suturing device is withdrawn from the puncture site prior tosecuring the loop.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an exemplary suturing device constructed inaccordance with the principles of the present invention.

FIG. 2 is a cross-sectional view of the suturing device of FIG. 1 takenalong line 2--2.

FIG. 3 is a cross-sectional view of the suturing device of FIG. 1 takenalong line 3--3 in FIG. 1.

FIG. 4 is a cross-sectional view of the suturing device of FIG. 1 takenalong line 4--4 in FIG. 1.

FIG. 5 is a detailed view of a needle guide of the suturing device ofFIG. 1 taken along line 5--5 in FIG. 1.

FIG. 6 is a perspective view of the proximal end of the suturing deviceof FIG. 1 with a handle assembly being shown broken away.

FIGS. 7-13 illustrate use of the suturing device of FIG. 1 in performinga vascular suturing procedure according to the method of the presentinvention.

DETAILED DESCRIPTION OF THE SPECIFIC EMBODIMENTS

Referring to FIG. 1, a suturing device 10 constructed in accordance withthe principles of the present invention will be described. The suturingdevice 10 comprises a guide body 12, a needle guide 14 secured to adistal end of the guide body 12, and a flexible tube 16 secured to adistal end of the needle guide 14. A pair of needles 20 are mounted withtheir distal ends in a holder 22 attached to a reciprocatable shaft 24.A handle assembly 26 is attached to a proximal end of the guide body 12and includes a pair of finger tabs 28 and a handle 30. The handle 30 isattached to a proximal end of the shaft 24 and can be pulled proximallyin order to draw the needles 20 from the tube 16, through the needleguide 14 and into the guide body 12, as will be describe in more detailhereinafter.

Rotatably received over the guide body 12 is a sleeve 32. As will bedescribed in greater detail hereinafter, the sleeve 32 may be rotated tofacilitate introduction of the suturing device 10 to a puncture site.The sleeve 32 will be sized to be introducible through a percutaneoustissue tract leading to a vascular puncture. In the case of percutaneouspunctures made to a patient's femoral artery in the drawing, the sleeve32 will typically have a diameter in the range from 3 mm to 15 mm,preferably from 7 mm to 10 mm, and length generally in the range from 30mm to 100 mm, preferably from 50 mm to 75 mm. The sleeve 32 will usuallybe inflexible, preferably being formed at least partially from metal ora hard plastic material.

As best shown in FIG. 4, the guide body 12 will define one or more axiallumens or channels therein. A central axial lumen 34 is provided forslidably receiving the shaft 24. The guide body 12 further includes ablood detection lumen 36 and a suture lumen 38 that pass therethrough.The blood detection lumen 36 is provided for receiving blood from thevessel to assist in positioning of the suturing device 10, and thesuture lumen 38 is provided for receiving two ends of a length of suture40 which are attached to the pair of needles 20 as described in greaterdetail hereinafter. A pair of needle receiving channels 42 are providedfor receiving the needles 20 upon reciprocation of the shaft 24.

Referring back to FIG. 1, the flexible tube 16 will be formed from aflexible plastic material, typically from polytetrafluorethylene (PTFE),fluorinated ethylene propylene (FEP), polyethylene, polyester, polyetherblock amide, and the like. The tube 16 will generally be circular incross-sectional geometry and will include a guide wire lumen 44 and acentral lumen 46 for holding the holder 22 and needles 20. The tube 16further includes a guide wire exit port 48 for allowing a guide wirethat is advanced proximally through the guide wire lumen 44 to exit fromthe side of the tube 16. The flexible tube 16 will preferably have adiameter in the range from about 2 mm (6F) to 10 mm (30F), morepreferably from 2.3 mm (7F) to 4.3 mm (13F). The length of the tube 16will typically be in the range from 200 mm to 400 mm, preferably from280 mm to 350 mm. The guide wire exit port 40 will usually be locatedabout 50 mm to 200 mm from the distal end of the needle guide 14.Optionally, the tube 16 may be provided with a distal J-tip 52 foratraumatic tracking through diseased vessels.

A plug 50 is provided to separate the guide wire lumen 44 from thecentral lumen 46 and is angled in the guide wire lumen 44 to assist indirecting the proximally advancing guide wire through the exit port 48.The exit port 48 allows the suturing device 10 to be introduced into ablood vessel in a "monorail" fashion so that only a distal portion ofthe tube 16 is tracked over the guide wire. In this manner, the profileof the suturing device 10 (and particularly the profile of the needleguide 14 and guide body 12) may be reduced. Reduction in size of thesuturing device 10 is advantageous in reducing the amount of traumaduring insertion of the device. Further, such a size reduction allowsfor the sleeve 32 to be included over the guide body 12, therebyeliminating the need for a separate predilator as discussed in greaterdetail hereinafter.

Referring now to FIGS. 2 and 6, construction of the handle assembly 26and sleeve 32 will be described in greater detail. Integrally formedbetween the finger tabs 28 is a stem 54 for receiving the handle 30. Thehandle 30 includes a key 56 that is received into an L-shaped slot 58 inthe stem 54. In this manner, the handle 30 may be slid into the stem 54with the key 56 being received into the L-shaped slot 58. The handle 30is then rotated in a clockwise direction to secure the handle 30 to thestem 54 and prevent axial translation of the shaft 24. To translate theshaft 24 and deploy the needles 20, the handle 30 is rotated in thecounter-clockwise direction so that the key 56 may be pulled from theslot 58. The handle 30 is then proximally translated to deploy theneedles 20.

The handle assembly 26 is preferably securely attached to the guide body12 so that the sleeve 32 may be rotated relative to the guide body 12when holding the handle assembly 26. The handle assembly 26 may besecurely fastened to the guide body 12 by any conventional means knownin the art, such as by gluing, molding, and the like, or alternatively,the handle assembly 26 may be formed as an integral part of the guidebody 12. One particular way to secure the handle assembly 26 to theguide body 12 is illustrated in FIG. 6 where the handle assembly 26includes a pair of pins 60 that are received into holes 62 in the guidebody 12. Included on the handle assembly 26 are a pair of tubes 64, 66which are aligned with the blood detection lumen 36 and the suture lumen38, with the length of suture 40 passing through the tube 66.

The finger tabs 28 are each provided with a detent 68 for engaging apair of grooves 70 in a hub 72 of the sleeve 32. The finger tabs 28 willusually be constructed of a resilient material, such as polycarbonate,so that the finger tabs 28 may be pressed together to remove the detents68 from the grooves 70. Upon removal of the detents 68 from the grooves70, the sleeve 32 may be rotated relative to the guide body 12 bymaintaining a grip on the finger tabs 28 with one hand and rotating thehub 72 with the other hand. As best shown in FIG. 3, the guide body 12includes a channel 74 about its periphery for receiving an annularcollar 76 of the sleeve 32. The collar 76 rests in the channel 74 toallow the sleeve 32 to be freely rotated about the guide body 12 whilepreventing axial translation of the sleeve 32 relative to the guide body12. Configuring the sleeve 32 in this manner is advantageous in that thesurgeon can quickly introduce the suturing device 10 to the puncturesite without the use of a predilator by merely disengaging the handleassembly 26 from the sleeve 32 and rotating the sleeve 32 as it isdirected into the tissue tract. A pointer 78 (see FIGS. 1 and 6) mayoptionally be provided to assist in determining the position of thesleeve 32 relative to the guide body 12.

Referring back to FIG. 3, the lumens 34, 36 and 38 in the guide body 12will be described in greater detail. The central lumen 34 extends fromthe flexible tube 16, through the needle guide 14, through the guidebody 12 and into the stem 54 of the handle assembly 26. Running thelength of the central lumen 34 is the shaft 24. In this way, the handle30 may be proximally translated to translate the shaft 24 through thecentral lumen 34 which in turn will translate the needles 20. Runninggenerally in parallel to the central lumen 34 is the blood detectionlumen 36 and the suture lumen 38. The blood detection lumen 36terminates in a marker port 80 in the needle guide 14, while the suturelumen 38 terminates in a suture port 81 and may optionally also includea marker port 82. In this way, the suture lumen 38 may optionally beconfigured as a "back-up" blood detection lumen (in additional toholding the suture 40) to assist in positioning the suturing device 10as described hereinafter. Passing through the suture lumen 38 is thelength of suture 40. The length of suture 40 is fashioned in the form ofthe loop with the free ends being attached to the needles 20 (see FIG.5) and with the looped end passing outside the suturing device 10through the tube 66 (see FIG. 1). Such a configuration facilitatesmanagement of the length of suture 40 during insertion of the suturingdevice 10 to a puncture site and during proximal translation of theneedles 20 to suture close the blood vessel. As the needles 20 areproximally advanced through the guide body 12, the length of suture 40is drawn distally through the blood detection lumen 38 where it iscompletely removed from the lumen 38 upon full deployment of the needles20. In this manner, the blood vessel may be sutured closed afterdeployment of the needles 20 by merely removing the ends of the suture40 from the needles 20, withdrawing the suturing device 10 from thepuncture site, and tying the free ends of the suture together.

Referring now to FIG. 5, needle guide 14 includes a pair of needle guidechannels 84. The needle guide channels 84 serve to house the sharpenedends of the needles 20 during insertion of the needle guide 14 into theblood vessel and also serve as guides to direct the needles 20 towardthe needle receiving channels 42 in the guide body during suturing ofthe blood vessel. The channels 84 are formed in a radially divergingpattern so that the needles 20 passing through the guide 14 will divergeas they pass through tissue over a tissue receiving region 86 at theproximal portion of the guide 14. A retaining band 88 is placed over thedistal end of the needle guide channels 84 to retain the needles 20 asthey pass therethrough. The retaining band 88 may also be used to securethe proximal end of the flexible tube 16. The needle guide 14 will havea generally circular periphery at its distal end adjacent the retainingband 88. The periphery, however, makes a transition to the tissuereceiving region 86 which is generally elliptical in geometry. Byproviding an elliptical profile at the tissue receiving region 86, thetissue surrounding the puncture to be closed will be disposed to providea better target for the needles 20 being passed therethrough. Inparticular, the needles 20 are oriented to pass over the major surfaces90 of the elliptical tissue receiving region 86. Since the tissue willbe partially closed together at this portion of the elliptical region(compared to a circular opening), it will be easier for the needles 20to find target tissue and become firmly anchored. Preferably, the totalperipheral distance over the needle guide 14 will not vary, with onlythe shape changing. By providing such a constant peripheral distance,hemostasis is maintained as the device is advanced and the tendency totear or otherwise damage the tissue surrounding the puncture will bereduced. The elliptical configuration of the tissue receiving region 86is further advantageous in that the needle trajectory angle relative tothe guide body 12 is reduced, which in turn reduces the necessarydiameter of the sleeve 32. As the needles 20 pass through the tissue,they are received into the needle receiving channels 42 in the guidebody 12 where they exit into the hub 72 (see FIG. 6).

Referring to FIGS. 1 and 3, use of the tubes 64 and 66 will be describedin greater detail. When the suturing device is introduced into a bloodvessel so that the marker port 80 lies within the blood vessel lumen(and is thus exposed to blood pressure), blood will appear at the openend of tube 64 indicating proper positioning of the device. Tube 66 isprovided to facilitate management of the suture 40 as previouslydescribed. If the market port 82 is included, blood will usually appearat the open end of tube 66 when the device is properly positioned. Inthis way, the tube 66 serves as a "back-up" indicator in the event thatno blood appears in the tube 64 (e.g. in the event that the lumen 36becomes clogged).

Referring now to FIGS. 7-13, use of the suturing device 10 for closing avascular puncture P will be described. The vascular puncture P is formedin the wall of a blood vessel BV which is located at the distal end of atissue tract TT by the Seldinger technique. An introducer sheath I isplaced over a guide wire GW passing percutaneously beneath the patient'sskin S. The situation illustrated in FIG. 7 will be typical of the endof a wide variety of interventional and/or diagnostic procedures,including angiography, ultrasonic imaging, angioplasty, atherectomy,intravascular drug delivery, and the like. It is desirable that theintroducer sheath I be removed and the vascular puncture be closed andsealed.

Referring now to FIGS. 7 and 8, the method of the invention begins bywithdrawing the introducer sheath I from the puncture P by sliding theintroducer I over the guide wire GW as shown by arrow 92. As shown inFIG. 8, the suturing device 10 is then introduced over the guide wire GWby passing the guide wire GW proximally through the flexible tube 16until the guide wire GW exits the exit port 48. The tube 16 is thenfurther advanced over the guide wire GW until the needle guide 14 isabout to enter the tissue tract TT and preferably before the exit port48 enters the blood vessel BV as shown. At this point, the guide wire GWis pulled from the tube 16 and is withdrawn from the puncture P asindicated by arrow 94. In this manner, the guide wire GW is removed fromthe puncture P prior to introduction of the needle guide 14 and theguide body 12.

Introduction of the needle guide 14 into the blood vessel BV isillustrated in FIG. 9. With the guide wire GW removed from the punctureP, the finger tabs 28 are grasped with one hand while the hub 72 isgrasped with the other hand. The finger tabs 28 are pressed together asindicated by arrows 96 so that the sleeve 32 may be rotated back andforth as indicated by arrow 98. The suturing device 10 is then furtheradvanced into the blood vessel BV to pass the needle guide 14 throughthe tissue tract TT. While the needle guide 14 is passing through thetissue tract TT, the sleeve 32 is rotated relative to the guide body 12to help dilate the tissue tract TT. Such dilation is advantageous inreducing the risk of injury to the blood vessel BV during insertion andpositioning of the needle guide 14. Furthermore, by providing the sleeve32, the use of a separate predilator is eliminated, thereby reducing thetime and trauma normally experienced with such predilation procedures.

Device 10 is introduced so that the blood marker ports 80, 82 just enterthe blood vessel BV lumen, as illustrated. At that point, the needleguide 14 will be properly positioned in the blood vessel BV, with theneedles 20 remaining undeployed within the tube 16.

Referring now to FIGS. 10-12, advancement of the needles 20 through theblood vessel wall will be described. To translate the needles 20, thehandle 30 is rotated counter-clockwise to disengage the key 56 from theslot 58 and is then proximally translated to proximally translate theshaft 24. As best shown in FIG. 10, the needles 20 will exit from theguide channels 84, pass into the vessel wall, and be directed toward theneedle receiving channels 42. As the needles 20 are drawn through theblood vessel wall, the length of suture 40 will be fed through thesuture port 81. As best shown in FIGS. 11 and 12, the needles 20 willthen be advanced into the receiving channels 42, with the necessarysuture being continually fed through the port 81. The needles 20 maythen be drawn proximally fully through the guide body 12 until theyemerge within the hub 72, with the suture 40 still attached thereto. Atthat point, the looped portion of the length of suture 40 will beremoved from the suture lumen 38 and will be free of the suturing device10.

The device 10 will then be removed from the tissue tract TT to allowclosure of the vascular puncture P. Preferably, preparation for removalwill be accomplished by pulling the needles 20 from the holder 22 andthen removing the ends of the length of suture 40 from the needles 20.Alternatively, the suture 40 may be removed from the sharpened end ofthe needles 20, and the needles 20 then reciprocated distally back intothe tube 16 in order to permit withdrawal of the suturing device 10. Itshould be noted that, for safety purposes, the needles 20 can always beretracted distally back into the tube 16 in order to terminate aprocedure and removed the suturing device 10.

When ready for removal, the suturing device 10 is partially withdrawnfrom the tissue tract TT and the free ends of the suture S1 and S2 (seeFIG. 13) are tied about the tube 16. The entire suturing device 10 isthen fully withdrawn with the free ends S1 and S2 remaining tiedtogether. As illustrated in FIG. 13, the knot in the suture 40 isadvanced through the tissue tract TT to the adventitial surface A usinga knot pusher 100, such as that illustrated in copending applicationSer. No. 08/252,310 (attorney docket no. 15508-14) the full disclosureof which is incorporated herein by reference. The suture can also befastened by using a wide variety of fasteners or other mechanicalclosure elements.

Although the foregoing invention has been described in some detail byway of illustration and example, for purposes of clarity ofunderstanding, it will be obvious that certain changes and modificationsmay be practiced within the scope of the appended claims.

What is claimed is:
 1. A suturing device comprising:a guide body; atranslating mechanism which translates at least one needle relative tothe guide body; a rotatable sleeve disposed over at least a distalportion of the guide body, wherein the rotatable sleeve is operablyattached to the guide body such that the rotatable sleeve may rotateabout the guide body while substantial axial movement of the rotatablesleeve relative to the guide body is prevented.
 2. A suturing device asin claim 1, wherein the rotatable sleeve is a rigid cylinder having alength in the range from 30 mm to 200 mm and a diameter in the rangefrom 3 mm to 15 mm.
 3. A suturing device as in claim 1, furthercomprising a flexible tube extending distally from the guide body,wherein the flexible tube includes a proximal end, a distal end, and aguide wire lumen extending proximally from the distal end andterminating in an exit port between the proximal and distal ends.
 4. Asuturing device as in claim 3, wherein the flexible tube has a length inthe range from about 20 cm to 40 cm, and further comprising a side portwhich is located at about 5 cm to 20 cm from the proximal end.
 5. Asuturing device as in claim 4, wherein the flexible tube has an outsidediameter in the range from about 2 mm to 10 mm.
 6. A suturing device asin claim 3, wherein the flexible tube further includes a central lumenextending distally from the proximal end, the central lumen being sizedto house the needle.
 7. A suturing device as in claim 1, furthercomprising a stopping mechanism to selectively prevent rotation of thesleeve.
 8. A suturing device as in claim 7, wherein the stoppingmechanism comprises a handle attached to the guide body, the handlehaving at least one detent for engaging a groove in the sleeve.
 9. Asuturing device as in claim 1, further comprising at least one blooddetection lumen passing through the guide body.
 10. A suturing device asin claim 9, further comprising a suture lumen passing through the guidebody, said suture lumen housing a length of suture.
 11. A suturingdevice comprising:a guide body; a translating mechanism to translate atleast one needle relative to the guide body; a flexible tube having aproximal end connected to the guide body, a distal end, and a guide wirelumen initiating at the distal end and terminating in a guide wire exitport between the proximal end and the distal end; and a sleeve rotatablydisposed about the guide body.
 12. A suturing device as in claim 11,further comprising a handle attached to the guide body, the handlehaving at least one detent for engaging a groove in the sleeve.
 13. Asuturing device as in claim 11, wherein the flexible tube has a lengthin the range from about 20 cm to 40 cm, and wherein the exit port islocated at about 5 cm to 20 cm from the proximal end.
 14. A suturingdevice as in claim 11, wherein the flexible tube has an outside diameterin the range from about 2 mm to 10 mm.
 15. A suturing device as in claim11, wherein the flexible tube includes means for directing a proximallyadvanced guide wire through the exit port.
 16. A suturing device as inclaim 11, wherein the rotatable sleeve is a rigid cylinder having alength in the range from 30 mm to 200 mm and a diameter in the rangefrom 3 mm to 15 mm.
 17. A suturing device as in claim 11, furthercomprising at least one blood detection lumen passing through the guidebody.
 18. A suturing device as in claim 17, further comprising a suturelumen passing through the guide body, said suture lumen housing a lengthof suture.
 19. A suturing device comprising:a guide body having aproximal end, a distal end, and an internal lumen; a needle guide havinga proximal end attached to the distal end of the guide body and a distalend having at least two needle guide channels, said needle guide furtherincluding a proximal region and a distal region, wherein the needleguide channels are disposed in the distal region and wherein theproximal region includes a recessed portion for receiving a section oftissue; a pair of needles; a length of suture having two ends, with eachend attached to one of the needles and with at least a portion of theremaining length of suture passing through the internal lumen of theguide body; a shaft reciprocatably mounted within the guide body andcarrying the needles to reciprocate the needles within the needle guidechannels; and a pair of receiving channels in the guide body which areseparate from the internal lumen, wherein the pair of needles areoperably connected to the shaft such that reciprocation of the shaftdraws the needles into the receiving channels and draws the length ofsuture from the internal lumen.
 20. A suturing device as in claim 19,further comprising a blood detection lumen which is separate from theinternal lumen.
 21. A method for suturing a puncture site in a bloodvessel wall disposed at the distal end of a percutaneous tissue tract,said method comprising:introducing a suturing device having a guide bodyand a flexible tube distally extending from the guide body to thepuncture site so that the guide body lies within the tissue tract andthe flexible tube lies within the blood vessel lumen; drawing a pair ofneedles with a length of suture therebetween from the flexible tubethrough the blood vessel wall adjacent the puncture and outward throughthe tissue tract, wherein at least a portion of the length of sutureextending between the pair of needles passes through a lumen in theguide body and is located outside the patient during the introductionstep, wherein the length of suture is pulled back through the guide bodylumen during the drawing step, and wherein the needles are received intoreceiving channels within the guide body which are separate from thelumen; and securing a loop in the suture to close the punctures.
 22. Amethod as in claim 21, wherein the suturing device includes a sleeverotatably disposed about the guide body, and further comprising rotatingthe sleeve relative to the guide body while introducing the guide bodyinto the puncture site.
 23. A method as in claim 21, wherein theintroducing step further comprises inserting the flexible tube over aguide wire and advancing the tube over the guide wire until the guidewire exits an exit port in the flexible tube.
 24. A method as in claim23, further comprising withdrawing the guide wire from the puncture siteprior to introducing the guide body into the tissue tract.
 25. A methodas in claim 21, further comprising positioning the suturing device byobserving blood within a marker lumen in the guide body having a sideport between the flexible tube and the distal end of the guide body. 26.A method as in claim 21, further comprising withdrawing the suturingdevice from the puncture site prior to securing the loop.
 27. A methodas in claim 21, further comprising inhibiting deployment of the needleduring the introducing step.